MANAN GENERAL UTILITY DRAINAGE CATHETER

{0}------------------------------------------------ K980193 Image /page/0/Picture/1 description: The image shows the logo for MDTECH Medical Device Technologies Inc. The logo is black and white and features the letters "MDTECH" in a bold, sans-serif font. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC." in a smaller font. The logo is simple and modern. ## MAY 27 1998 4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662 ## 510(k) SUMMARY | APPLICANT: | Medical Device Technologies, Inc.<br>4445-310 SW 35th Terrace<br>Gainesville, FL 32608 | |--------------------------|----------------------------------------------------------------------------------------| | CONTACT: | Karl Swartz<br>Quality Assurance Manager | | TELEPHONE: | (352)338-0440<br>fax (352)338-0662 | | TRADE NAMES: | Manan™ General Utility Drainage Catheter | | COMMON NAME: | Drainage catheter | | CLASSIFICATION NAME: | §878.4200-Introduction Drainage Catheter and Accessorie | | SUBSTANTIAL EQUIVALENCE: | | General Utility Drainage Catheter Manan Medical Products K953713 ## DESCRIPTION OF DEVICE: Manan drainage catheters are made from a biocompatible implantable urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in various end configurations: Pigtailloop(Locking and non-locking), and "J" type. Also included with the catheters are stiffening cannula and trocar sets. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human profiles facing right, layered on top of each other. The profiles are rendered in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 7 1998 Mr. Karl Swartz ·Quality Manager Medical Device Technologies Incorporated 4445-310 South West 35th Terrace Gainesville, Florida 32608 K980193 Re: Manan™ General Utility Drainage Catheter Trade Name: Regulatory Class: II Product Code: LJE Dated: April 16, 1998 Received: April 17, 1998 Dear Mr. Swartz: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 54.2 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {2}------------------------------------------------ Page 2 - Mr. Swartz This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification.for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Colia M. Whitten, Ph.D., M. Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K980193 Image /page/3/Picture/1 description: The image is a logo for MDTECH Medical Device Technologies Inc. The logo is black and white and features the company name in a bold, sans-serif font. The letters "MDTECH" are stacked on top of the words "MEDICAL DEVICE TECHNOLOGIES INC". The logo is simple and modern, and it is likely used on the company's website, marketing materials, and products. 445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662 Page_1_of_1_ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Manan™ General Utility Drainage Catheter Indications for Use: The Manan™ General Utility Drainage Catheter is for percutaneous nephrostomy, abcess, cyst, and other small fluid collection drainage. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Office Evaluation (cont.) (Division Sign-Off) Division of General Read 5 I U(k) Number Prescription Use_X (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96)